1) Support the clinical research at NIDCR DIR through assistance with protocol writing, scientific reviewing, regulatory compliance (FDA and OHRP), database development, AE/SAE reporting, subject scheduling, study coordinator support and research nursing suppport In FY09 the CSS revised and/or upgraded the clinical support services for a number of clinical research protocols, set up a new web based system for SAE reporting, and added research nursing support 2) Support clinical research quality and oversight through formal external study monitoring, Data Safety Monitoring Committee (DSMC) and internal quality controls In FY09 NIDCR instituted a standing DSMC and supported oversight activities. 3) Support the NIDCR Institutional Review Board (IRB) In FY09 the NIDCR instituted an electronic system for protocol management, revised procedures for IRB review and added new expertise to the IRB. 4) Provide dental and oral surgery medical consultations for subjects in the Clinical Center, at NIDCR and at other NIH Institutes In FY09 the NIDCR DIR hired a new oral surgeon to support NIDCR DIR clinical research and provided oral surgery and dental consultations to other NIH institutes. 5) Support the Clinical Director's (CD) Office In FY09 the CSS supported the CD Office to facilitate clinical research development and clinical protocol performance and quality
| Bassim, Carol W; Ambatipudi, Kiran S; Mays, Jacqueline W et al. (2012) Quantitative salivary proteomic differences in oral chronic graft-versus-host disease. J Clin Immunol 32:1390-9 |
